OES CYSTONEPHROFIBERSCOPE

Basic Information

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Primary DI: 04953170339424
• Version / Model: OLYMPUS CYF-5A
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 6
• Public Version Date: 2024-01-15
• Public Version Status: Update
• Public Device Record Key: 8d9f165d-12fa-454a-ba29-dcf9a2f1c412
• Distribution End Date: 2024-01-12

Device Description

CYF-5A Flex CystoNephro Fiberscope w/Asp

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Ethylene Oxide", "High-level Disinfectant"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FAJ	Cystoscope and accessories, flexible/rigid	Gastroenterology, Urology	876.1500	2
FDI	SNARE, FLEXIBLE	Gastroenterology, Urology	876.4300	2
FCL	FORCEPS, BIOPSY, NON-ELECTRIC	Gastroenterology, Urology	876.1075	1
FGA	Kit, nephroscope	Gastroenterology, Urology	876.1500	2
KGE	FORCEPS, BIOPSY, ELECTRIC	Gastroenterology, Urology	876.4300	2
KNS	Unit, electrosurgical, endoscopic (with or without accessories)	Gastroenterology, Urology	876.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46722	Flexible fibreoptic cystonephroscope	An endoscope with a flexible inserted portion intended for the visual examination/treatment of the bladder, the urethra (including the prostate region), and the kidneys. It is inserted into the urethra through the natural urinary orifice, and percutaneously into the renal pelvis for the kidneys during an endoscopic procedure. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used for the removal/crushing of stones, pyelitis, and renal failure (nephroscopy); and treatment of lesions of the urinary bladder/posterior urethra, or to evaluate bladder control/incontinence (cystoscopy). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170339424	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]